TY - JOUR
T1 - Once-daily oral sarecycline 1.5 mg/kg/day is effective for moderate to severe acne vulgaris
T2 - Results from two identically designed, phase 3, randomized, double-blind clinical trials
AU - Moore, Angela
AU - Green, Lawrence J.
AU - Bruce, Suzanne
AU - Sadick, Neil
AU - Tschen, Eduardo
AU - Werschler, Philip
AU - Cook-Bolden, Fran E.
AU - Dhawan, Sunil S.
AU - Forsha, Douglass
AU - Gold, Michael H.
AU - Guenthner, Scott
AU - Kempers, Steven E.
AU - Kircik, Leon H.
AU - Parish, Jennifer L.
AU - Rendon, Marta I.
AU - Rich, Phoebe
AU - Stein-Gold, Linda
AU - Tyring, Stephen K.
AU - Weiss, Robert A.
AU - Nasir, Adnan
AU - Schmitz, Carsten
AU - Boodhoo, Terry I.
AU - Kaoukhov, Alexandre
AU - Berk, David R.
N1 - Funding Information:
This study was sponsored by Allergan plc, Dublin, Ireland. Writing and editorial assistance was provided to the authors by Peloton Advantage, Parsippany, NJ, and was funded by Allergan plc. Neither honoraria nor other form of payments were made for authorship.
Publisher Copyright:
© 2018 Journal of Drugs in Dermatology. All rights reserved.
PY - 2018/9
Y1 - 2018/9
N2 - Background: Side effects may limit the use of current tetracycline-class antibiotics for acne. Objective: Evaluate the efficacy and safety of once-daily sarecycline, a novel, narrow-spectrum tetracycline-class antibiotic, in moderate to severe acne. Methods: Patients 9–45 years with moderate to severe facial acne (Investigator’s Global Assessment [IGA] score ≥3, 20–50 inflammatory and ≤100 noninflammatory lesions, and ≤2 nodules) were randomized 1:1 to sarecycline 1.5 mg/kg/day or placebo for 12 weeks in identically designed phase 3 studies (SC1401 and SC1402). Results: In SC1401 (sarecycline n=483, placebo n=485) and SC1402 (sarecycline n=519, placebo n=515), at week 12, IGA success (≥2-grade improvement and score 0 [clear] or 1 [almost clear]) rates were 21.9% and 22.6% (sarecycline), respectively, versus 10.5% and 15.3% (placebo; P<0.0001 and P=0.0038). Onset of efficacy in inflammatory lesions occurred by the first visit (week 3), with mean percentage reduction in inflammatory lesions at week 12 in SC1401 and SC1402 of −51.8% and −49.9% (sarecycline), respectively, versus −35.1% and −35.4% (placebo; P<0.0001). Onset of efficacy for absolute reduction of noninflammatory lesion count occurred at week 6 in SC1401 (P<0.05) and week 9 in SC1402 (P<0.01). In SC1401, the most common TEAEs (in ≥2% of either sarecycline or placebo group) were nausea (4.6% [sarecycline]; 2.5% [placebo]), nasopharyngitis (3.1%; 1.7%), headache (2.7%; 2.7%), and vomiting (2.1%; 1.4%) and, in SC1402, nasopharyngitis (2.5%; 2.9%) and headache (2.9%; 4.9%). Most were not considered treatment-related. Vestibular (dizziness, tinnitus, vertigo) and phototoxic (sunburn, photosensitivity) TEAEs both occurred in ≤1% of sarecycline patients. Gastrointestinal TEAE rates for sarecycline were low. Among females, vulvovaginal candidiasis (SC1401: 1.1% [sarecycline] and 0 [placebo]; SC1402: 0.3% and 0) and mycotic infection (0.7% and 0; 1.0% and 0) rates were low. Conclusion: The narrow-spectrum antibiotic sarecycline was safe, well tolerated, and effective for moderate to severe acne, with low rates of side effects common with tetracycline antibiotics.
AB - Background: Side effects may limit the use of current tetracycline-class antibiotics for acne. Objective: Evaluate the efficacy and safety of once-daily sarecycline, a novel, narrow-spectrum tetracycline-class antibiotic, in moderate to severe acne. Methods: Patients 9–45 years with moderate to severe facial acne (Investigator’s Global Assessment [IGA] score ≥3, 20–50 inflammatory and ≤100 noninflammatory lesions, and ≤2 nodules) were randomized 1:1 to sarecycline 1.5 mg/kg/day or placebo for 12 weeks in identically designed phase 3 studies (SC1401 and SC1402). Results: In SC1401 (sarecycline n=483, placebo n=485) and SC1402 (sarecycline n=519, placebo n=515), at week 12, IGA success (≥2-grade improvement and score 0 [clear] or 1 [almost clear]) rates were 21.9% and 22.6% (sarecycline), respectively, versus 10.5% and 15.3% (placebo; P<0.0001 and P=0.0038). Onset of efficacy in inflammatory lesions occurred by the first visit (week 3), with mean percentage reduction in inflammatory lesions at week 12 in SC1401 and SC1402 of −51.8% and −49.9% (sarecycline), respectively, versus −35.1% and −35.4% (placebo; P<0.0001). Onset of efficacy for absolute reduction of noninflammatory lesion count occurred at week 6 in SC1401 (P<0.05) and week 9 in SC1402 (P<0.01). In SC1401, the most common TEAEs (in ≥2% of either sarecycline or placebo group) were nausea (4.6% [sarecycline]; 2.5% [placebo]), nasopharyngitis (3.1%; 1.7%), headache (2.7%; 2.7%), and vomiting (2.1%; 1.4%) and, in SC1402, nasopharyngitis (2.5%; 2.9%) and headache (2.9%; 4.9%). Most were not considered treatment-related. Vestibular (dizziness, tinnitus, vertigo) and phototoxic (sunburn, photosensitivity) TEAEs both occurred in ≤1% of sarecycline patients. Gastrointestinal TEAE rates for sarecycline were low. Among females, vulvovaginal candidiasis (SC1401: 1.1% [sarecycline] and 0 [placebo]; SC1402: 0.3% and 0) and mycotic infection (0.7% and 0; 1.0% and 0) rates were low. Conclusion: The narrow-spectrum antibiotic sarecycline was safe, well tolerated, and effective for moderate to severe acne, with low rates of side effects common with tetracycline antibiotics.
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M3 - Article
C2 - 30235387
AN - SCOPUS:85059079391
SN - 1545-9616
VL - 17
SP - 987
EP - 996
JO - Journal of Drugs in Dermatology
JF - Journal of Drugs in Dermatology
IS - 9
ER -